Rapid Research in Diagnostics Development for TB Network

Criteria the registry did not label

• Novel TB triage and diagnostic tests:
• We will include non-hospitalized adults (age ≥ 12 years) with either 1) cough ≥2 weeks' duration, a commonly accepted criterion for identifying people with presumed pulmonary TB (to facilitate standardization across sites and comparison of test performance across sub-groups or 2) risk factors for which TB screening is recommended (HIV infection, self-reported close contact, history of mining work). People with risk factors will be included if they screen positive for TB based on WHO-recommended screening tools as specified below:
• Positive TB screening definitions by risk factor:
• PLHIV (Risk Factor), CRP \>5 mg/dL OR abnormal CXR (Positive TB screening definition)
• Self-reported Close Contact (Risk Factor), abnormal CXR (Positive TB screening definition)
• History of mining work (Risk Factor), abnormal CXR (Positive TB screening definition)
  • We will exclude people who:
• completed latent or active TB treatment within the past 12 months (to increase TB prevalence and reduce false-positive results, respectively);
• have taken any medication with anti-mycobacterial activity (including fluoroquinolones) for any reason, within 2 weeks of study entry (to reduce false-negatives);
• reside \>20km from the study site or are unwilling to return for follow-up visits; or
• are unwilling to provide informed consent
  • Novel TB rDST assays:
  • We will include adults (age ≥12 years) who are positive for TB and RIF resistance according to routine diagnostic testing (based typically on Xpert MTB/RIF, Xpert MTB/RIF Ultra, or Hain MTBDRplus). We will exclude people who:
• have negative or contaminated results on all baseline (i.e., enrollment) sputum cultures
• are unable to provide at least two sputum specimens of 3 mL each within one day of enrollment
• are unable or unwilling to provide informed consent
  • Assessment of the usability of novel TB tests:
  • We will include health workers at each clinical site who are 1) aged ≥18 years and 2) involved in routine TB testing (collecting specimens for or performing TB tests). We will exclude staff who are unwilling to provide informed consent.